Drug
substance GMP
manufacturing | PMBP is currently focusing on biopharmaceuticals such as monoclonal antibodies and antibody fragments, expressed in mammalian cell cultures. The pilot plant is operating in two 200L single use. The GMP plant is operating in 300L stainless steel bioreactors and in 1,000L single use technology. All bioreactors are from Sartorius-Stedim. Harvest is performed by Westphalia centrifugation and depth filtration. The classical downstream processing is on affinity chromatography, AIEX and CIEX chromatography ultrafiltration, diafiltration and sterile filtration in the corresponding scale. Viral inactivation is performed at low pH and nanofiltration without jeopardizing the high quality of our therapeutics.
For commercialization of our products we have a conceptual design for 2x2,500L as well as for 2x10,000L stainless steel processes on our premises in Changzhou. |
